MAUDE Adverse Event Report: CONCORD MANUFACTURING DRY ACID 99 GALLON UNIT, ASSY TO SHIP; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Catalog Number RTL160148

Device Problems Thermal Decomposition of Device (1071); Smoking (1585); Electrical Shorting (2926)

Patient Problem No Patient Involvement (2645)

Event Date 11/01/2016

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental medwatch report will be submitted upon completion of this activity.

Event Description

A biomedical technician (biomed) at the user facility reported that the dry acid mixer fill valve shorted out, which caused the unit to smoke.The room the mixer was housed in filled with smoke, so the building was evacuated.No flames or sparks were visible.There was no harm to staff or patients.Following the event, the unit was removed from service and examined visually to identify the source of the smoke.After partial disassembly of the unit, the electrical plug for the solenoid fill valve was found to be severely burnt.The valve itself was also partially burnt.Reportedly, a batch was being mixed by one of the staff when the issue occurred.The machine failed to switch to mix when the button was pressed, so the unit was set to step mode to initiate the mix.The smoke occurred shortly thereafter.The user facility further noted that the local power company recently installed a surge protector at the facility.The unit is available to be returned to the manufacturer for evaluation.A replacement dry acid mixer is scheduled to be installed to replace the complaint device.

Manufacturer Narrative

The dry acid 99 gallon mixer was returned to the manufacturer for physical evaluation.The machine was partially disassembled upon return.A visual inspection revealed an electrical plug for a solenoid valve was severely burned and removed from the unit.No discrepancies were found during the internal inspection of the panel assembly; no indications of burn damage to the components.The internal inspection revealed a solenoid valve with burn damage, rust, and the build-up of concentrate crystals from a fluid leak.The inspection also showed torn plumbing tape at the connection of a t-fitting and hose in the nozzle sub-assembly b.The connection also had concentrate crystals which indicate a fluid leak.The pvc pipe joint to the nozzle sub-assembly b t-fitting was inspected.The plumbing tape was found to be bound up and bunched on the pipe thread, which caused the tape to tear from the thread.No mechanical or electrical tests could be performed on the machine as it was received in a condition that did not permit any additional testing.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances or any associated rework during the manufacturing process which could be associated with the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was able to confirm the failure mode.The failure analysis found that the burn damage to the electrical plug and the solenoid valve were caused by a plumbing leak.Therefore, the complaint has been deemed confirmed.

• Brand Name: DRY ACID 99 GALLON UNIT, ASSY TO SHIP
• Type of Device: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6125187
• MDR Text Key: 60869008
• Report Number: 2937457-2016-01187
• Device Sequence Number: 1
• Product Code: KPO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131611
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RTL160148
• Other Device ID Number: 00840861101009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1